Brand Name

    US Brand Name

    Sular


    Description

    Nisoldipine is used alone or together with other medicines to treat high blood pressure. High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

    Nisoldipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, it relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet, Extended Release

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of nisoldipine in the pediatric population. Safety and efficacy have not been established ..

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nicardipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving nisoldipine .

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Itraconazole
    • Ketoconazole
    • Levoketoconazole

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abametapir
    • Adagrasib
    • Atazanavir
    • Avacopan
    • Carbamazepine
    • Ceritinib
    • Clarithromycin
    • Clonidine
    • Clopidogrel
    • Cobicistat
    • Conivaptan
    • Dabrafenib
    • Dantrolene
    • Darunavir
    • Digoxin
    • Epirubicin
    • Fedratinib
    • Fexinidazole
    • Fluconazole
    • Fosnetupitant
    • Lacosamide
    • Lonafarnib
    • Mavacamten
    • Melphalan
    • Mibefradil
    • Netupitant
    • Omaveloxolone
    • Phenobarbital
    • Ponesimod
    • Primidone
    • Ritlecitinib
    • Tacrolimus
    • Tazemetostat

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Cimetidine
    • Dalfopristin
    • Fosphenytoin
    • Indinavir
    • Phenytoin
    • Quinidine
    • Quinupristin
    • Rifampin
    • Rifapentine

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Grapefruit Juice

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Congestive heart failure or
    • Coronary artery disease or
    • Low blood pressure—Use with caution. May increase risk of serious side effects .
    • Liver disease—Use with caution. The effects of nisoldipine may be increased because of the slower removal of the medicine from the body .

    Proper Use

    In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

    Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

    Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

    Take this medicine exactly as directed even if you feel well. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

    Swallow the extended release tablet whole. Do not break, crush, or chew it. It is best to take this medicine on an empty stomach .

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (extended release tablets):
      • For high blood pressure:
        • Adults—10 to 20 milligrams (mg) once a day. Your doctor may increase your dose if needed.
        • Children—Use and dose must be determined by your doctor .

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

    It is very important that your doctor check your blood regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away .

    Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

    This medicine may cause dizziness, lightheadedness, or fainting. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you experience these effects.

    Nisoldipine should not be taken with a high-fat meal or with grapefruit juice or other grapefruit products because these may increase the levels of nisoldipine in the body .


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Bloating or swelling of face, arms, hands, lower legs, or feet
    • rapid weight gain
    • tingling of hands or feet
    • unusual weight gain or loss

    Less common

    • Chest pain
    • dizziness, lightheadedness, or fainting
    • fast, irregular, pounding, or racing heartbeat or pulse
    • feeling of warmth or heat
    • flushing or redness of skin, especially on face and neck
    • headache
    • rash
    • sweating

    Rare

    • Chest tightness
    • shortness of breath
    • swelling of the arms, face, legs, lips, tongue, or throat

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

    • Body aches or pain
    • congestion
    • cough
    • dryness or soreness of throat
    • fever
    • heartbeat sensations
    • hoarseness
    • pain or tenderness around eyes and cheekbones
    • runny nose
    • stuffy nose
    • tender, swollen glands in neck
    • trouble in swallowing
    • voice changes

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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